FDA.reportPublic FDA data

DOJOLVI

Product NDC
69794-050
11-digit product format
697940050
Labeler code
69794
Product ID
69794-050_a89d49c1-092a-4911-bbcc-611479f4c444
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triheptanoin
Dosage form
LIQUID
Route
ORAL
Labeler
Ultragenyx Pharmaceutical Inc.
Application
NDA213687
Marketing category
NDA
Marketing start
2020-07-01
Substance
TRIHEPTANOIN
Active strength
.96 g/mL
Pharmacologic classes
Medium-chain Triglyceride [EPC], Triglycerides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DOJOLVI
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIHEPTANOIN.96 g/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2P6O7CFW5K
Rxcui2383555, 2383561

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
124351b2-6dbf-42d0-9ea7-f0e299215f9aProduct name120210115

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69794-050-502022-11-02C16284748780-1e4f33bdf-aaab-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use DOJOLVI safely and effectively. See full prescribing information for DOJOLVI. DOJOLVI ® (triheptanoin) oral liquid Initial U.S. Approval: 2020
69794-050-502022-11-02C16284748780-1e4f33bdf-aaab-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use DOJOLVI safely and effectively. See full prescribing information for DOJOLVI. DOJOLVI ® (triheptanoin) oral liquid Initial U.S. Approval: 2020
69794-050-502022-07-29C16284748780-1e4f33bdf-aaab-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use DOJOLVI safely and effectively. See full prescribing information for DOJOLVI. DOJOLVI ® (triheptanoin) oral liquid Initial U.S. Approval: 2020
69794-050-502022-07-29C16284748780-1e4f33bdf-aaab-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use DOJOLVI safely and effectively. See full prescribing information for DOJOLVI. DOJOLVI ® (triheptanoin) oral liquid Initial U.S. Approval: 2020

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69794-050-50DOJOLVI500 mL in 1 BOTTLE, GLASSLIQUID50017
69794-050-50DOJOLVI1 in 1 CARTONLIQUID117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69794-050-50ML - Milliliter69794-05077856291-d830-4889-b623-0021ff48b9ab12020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69794-050DOJOLVI (TRIHEPTANOIN) LIQUID [ULTRAGENYX PHARMACEUTICAL INC.]14Current NDC, Legacy NDC, 2 package rows20250302_4cfeb8bd-143e-4dd7-bc34-b0bcda02460d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2383561DOJOLVI 8.3 kcal/mL (100 % ) Oral SolutionPSN4cfeb8bd-143e-4dd7-bc34-b0bcda02460d17
2383555triheptanoin 8.3 kcal/mL (100 % ) Oral SolutionPSN4cfeb8bd-143e-4dd7-bc34-b0bcda02460d17
2383561triheptanoin 1000 MG/ML Oral Solution [Dojolvi]SBD4cfeb8bd-143e-4dd7-bc34-b0bcda02460d17
2383555triheptanoin 1000 MG/ML Oral SolutionSCD4cfeb8bd-143e-4dd7-bc34-b0bcda02460d17
2383561Dojolvi 100 % Oral SolutionSY4cfeb8bd-143e-4dd7-bc34-b0bcda02460d17
2383561Dojolvi 1000 MG/ML Oral SolutionSY4cfeb8bd-143e-4dd7-bc34-b0bcda02460d17
2383555triheptanoin 100 % Oral SolutionSY4cfeb8bd-143e-4dd7-bc34-b0bcda02460d17
2383555triheptanoin 8.3 kcal/ML Oral SolutionSY4cfeb8bd-143e-4dd7-bc34-b0bcda02460d17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69794-050-50697940050501 BOTTLE, GLASS in 1 CARTON (69794-050-50) / 500 mL in 1 BOTTLE, GLASS2020-07-010000-00-00NoNoCurrent